Randomized controlled trial of Japanese herbal medicine, daikenchuto for preventive effects of bowel dysfunction after adult liver transplantation.
Not Applicable
- Conditions
- liver transplant recipient (including organ transplant from a brain-dead donor)
- Registration Number
- JPRN-UMIN000014326
- Lead Sponsor
- Division of Hepato-Biliary-Pancreatic Surgery and Transplantation, Department of Surgery, Graduate School of medicine, Kyoto University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients with uncontrolled active infection , excluding infection in the liver and gall bladder 2) patients with uncontrolled cancer , excluding cancer in the liver 3) patients with the disease that cannot enforce a liver transplant safely 4) patients with the history of mechanical ileus , or assumed the intra-abdominal adhesion after gastrointestinal surgery. 5) patients taking prokinetic agent, antipsychotic drug, antidepressant, herbal medicine 6) females who are in pregnancy or lactation, may be pregnant 7) patients whom were considered inappropriate by the doctors for participation in this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) intake of total calories in oral or enteral nutrition on postoperative day 7. 2) gastrointestinal symptoms on postoperative day 7. : NRS
- Secondary Outcome Measures
Name Time Method 1) intake of total calories in oral or enteral nutrition. 2) gastrointestinal symptoms: NRS 3) recovery of the gastrointestinal function after liver transplantation.(time to the first defecation.) 4) quality of life : GSRS score 5) assessment of liver function 6) rate of liver regeneration 7) rate of the bacteremia after liver transplantation 8) the trough of the immunosuppressive drug 9) acute cellular or humoral rejection. 10) the rate of leaving hospital on postoperative 2 months 11) portal venous blood flow 12) volume of ascites fluid 13) adverse event 14) adverse effect